[Reader-list] Threats to ayurvedic Industry

[harilal madhavan]

M S HARILAL/ SARAI INDEPENDENT FELLOW 2007/ FOURTH POSTING/ AYURVEDIC
INDUSTRY: SPECIFIC CHALLENGES AS EVIDENCED FROM THE STUDY OF ORGANIZED
SECTOR (MAINLY ISSUES FROM CASE OF OUSHADHI)

This posting I mainly refer to the threats faced by the organised
sector as evidenced from the case of Oushadhi, Kerala.

While the industry is very much receptive to innovation and product
pattern shift, the major challenges faced by the sector are many.
Other than the general problems like competition from other countries
(in the case of ayurveda, it is China), cost competitiveness and
demand enrichment, investing on innovation and technology etc. it face
some unique problems like a) Availability of right and quality raw
material, especially medicinal plants b) standardization, and
validation of Ayurvedic products as per the modern trials for selling
larger market outside and c) Problems regarding the protection under
IPR regimes. That means upgrading the domestic market or strengthening
industry from within alone will not be sufficient, but an effort
should be there to solve major external problems. The common feature
of these issues is state has a crucial role in assuaging all these
issues. They are:

a)	Depletion of medicinal and aromatic plants

'Right and timely availability of raw material' is going to be a
crucial factor if not, one of the biggest problems that this industry
is going to face in the coming future. 'Right' here means of right
kind and right quality. Depletion of the same due to ruthless
cultivation and forest destruction is of major concern. Since the
demand for medicinal plants is a derived demand from the demand for
Ayurvedic medicines and related products, and mainly 80% of the
Ayurvedic raw material consists of medicinal plants, the growth of
Ayurvedic industry will result in consequently a same increase in the
medicinal plant demand. An estimate shows that Ayurvedic industry is
growing at a rate of 12 to 15% in Kerala (Harilal, 2004). A same
growth can be expected in other parts of the country also. This will
put an additional compulsion on the medicinal plant sector to provide
matured and specific quality raw material for the growing industry.
This problem has been addressed in international arena through various
conservation activities and cultivation promoting programmes. Many
studies (MAPPA 1998, Suneetha and Chandrakanth 2001, Devi and Joseph
2003) have addressed the problem of economic scarcity of medicinal
plants in relation to the demand from the pharmacies in and outside
Kerala.

A study by Suneetha and Chandrakanth (2002), using the real price
increase as a proxy of relative scarcity, also reach the conclusion
that many plants are getting extinct in Indian forests. There are
various medicinal plants which the firms in the country are getting
from outside, since it is no longer available in the country. At the
same time, India is supplying around 14% of the medicinal plant needed
in the European Union herbal market. This shows that, we have
comparative advantage in the collection and cultivation of some of the
plants while we have disadvantage in some others. So the promotion of
both in-situ and ex-situ cultivation and various other methods like
gene banks and herbal parks should be encouraged nation wide. This
conservation issues are hitting the headings at present especially
after the Convention on Biological Diversity (1992), in which the
first declaration regarding the rights of indigenous community and
equal sharing is being made and need for conservation also emphasized.
Direct ways of protection and indirect methods through incentive
policies should be pursued. Since a large literature on this issue is
available, here we will concentrate more on other concerns.

b)	Standardizing the products/process for the world market*

The main issues the industry faces in terms of quality and standardization are:

Lack of Product and process validation: Once a product is conceived
the efficiency of the product has to be proved authentically.  For
which internationally accepted non-clinical trials to prove the
efficacy of the product in animals abiding OECD guidelines, toxicity
studies, pharmacokinetics, pharmacodynamics, bio-equivalence etc.
should be used. As far as Ayurvedic medicines are concerned no such
validation methodology has been used for generations together.  Since
the toxicity of the product is not known, the action of the product in
human body cannot be known and thus the modern medical community will
not accept Ayurvedic product as a medicine. There should be uniform
process techniques for each product and this should not be changed
from batch to batch so as to get uniform products from each batch.
There should be a Standard Operating Procedure for each product and
this should be clearly followed and the standard operating procedure
should start right form the selection of raw materials and continues
till the final product gets packed.  There should be a uniform
procedure for each product manufacturing, which is called process
validation. Till date nothing has been developed in the field of
Ayurveda for Process Validation (Varghese, 2005).

Lack of Quality Control and quality assurance: Quality Control refers
to the processes involved in maintaining the quality of validity of a
manufactured product.  Regardless of the form of herbal preparation,
some degree of quality control is necessary. Currently, there is no
organization or government body that certifies a product is 'labeled
correctly'. Without proper QC, there is no assurance that the herb
contained in the bottle is the same as what is stated on its outside
label.  The solution to this is for manufacturers and suppliers of
herbal products to adhere to QC standards and good manufacturing
practices.  With improvements in the identification of plants by
laboratory analysis, consumers should at least be guaranteed that the
right plant is being used. Currently, only a few manufacturers in
India adhere to complete QC and good manufacturing procedures
including microscopic, physical, chemical and biological analysis. In
general, it is believed that if the active components of a particular
herb are known, whatever forms the herb product is, the herb should be
analyzed to ensure that it contains these components at an
acceptable/standardized level.  More accurate dosages can then be
given for optimal use of the herb. Currently, in many countries,
numerous standardized extracts fulfill requirements for marketing as
drugs. During the production process, there should be a continuous
monitoring of a quality assurance department to see that all quality
parameters were strictly followed during manufacturing.  If we go
through the specifications of international standards like USFDA, TGA
etc., they have definite standards for each and every activity, which
gives better performance during the manufacturing stage. If we can
develop such guidelines and evolve specific procedure, our entry to
the international herbal pharmaceutical market will be much easier and
we can take the advantages of WTO, by patenting our processes and
products.

Lack of GLP and GMP: GLP regulations were intended for toxicity
testing only.  It was reserved for labs undertaking animal studies for
pre-clinical work.  Some laboratories follow GLP's whenever the
studies are to be used to support applications for research or
marketing studies to be submitted to the FDA. GLP regulates all
non-clinical safety studies that support or are intended to support
applications for research or marketing permits for products regulated
by the FDA or other similar national legislation. Good Manufacturing
Practice (GMP) regulates manufacturing and its associated quality
control (in contrast to GLP which covers more drug development
activities). GMP predates GLP. GMP regulations have been developed to
ensure that medicinal (pharmaceutical) products are consistently
produced and controlled to the quality standards appropriate to their
intended use.  GAPs stress the selection of correct germ plasm with
high content of stable active components. GAPs also establish
standards for noxious and harmful contaminants like heavy metals,
pesticide residues and microbes in plants. Chinese success story
should work for India as a model.

Lack of Toxicological/ Safety Studies: The Evaluation of the toxicity
and adverse drug reaction of the herbal preparation has been a
neglected area, as herbs are considered as natural products and,
therefore safe. This lack of information makes it difficult to compare
the benefit-risk profile of herbal medicines. Standardization doesn't
mean only for the products, but the collection, processing of raw
material and the final product should be standardized. Availability of
the desired genotype of plant in the required quantity, free from
toxic contaminants and with desired therapeutic activity has also very
critically considered. This issue gains relevance in the  current
context were many countries like UK and Canada has been banned the
Indian Ayurvedic products, with the allegation that most of these
contains metal content, and similar allegation was there regarding
some products that they contain steroids. But most of the experts  has
the opinion that, the problem is actually, created by the simple drugs
and compound drugs. Simple drugs the standardization is simple and it
can be followed in the modern lines. But in the case of compound drugs
it is very difficult to find the therapeutic quality of each and every
component. So while in ayurveda when poly herbal product is validated
we have a chemical finger printing mechanism for validation up to
three ingredients are possible, but difficult. But most of the
Ayurvedic medicines, it is very difficult to go for these chemical
finger printing. For example the case of dasamoolarishtam, one cannot
check the quality by taking each and every ingredient of the
formulation.

So in the case of standardization, we can follow the efficiency model
China has been put forward, through Good Agricultural Practice (at the
collection/cultivation level), Good Manufacturing Practice (at the
manufacturing level) and Good Clinical Practice (at the trial
standardization level). India has already adopted the Good
Manufacturing Practice and many firms are following the guide lines
set.

c)	Inadequacies with existing patent laws and protection of Ayurvedic knowledge

Inadequacies in the Intellectual Property Regime are of great
relevance when the fact of community ownership and secretive nature of
Traditional medicine is considered. In addition to this, in the case
of traditional medicine, like Ayurveda, how the grass-root
innovations, which have high commercial significance, can be protected
and equally shared is of major concern. Though we have some successful
examples like Jeevani , at present, the requirements for protection
provided under international standards of patent law and most national
patent laws are inadequate to protect traditional knowledge and
biodiversity. For example, traditional skills in manual and spiritual
therapies are different from those in modern practice and there is no
record of who was the inventor. Existing conventional patent law can
and does protect pharmaceutical products. However, herbal medicines
and herbal products are different from chemical drugs. The
intellectual property standards established by the Agreement of
Trade-Related Aspects of Intellectual Property Rights (TRIPS
Agreement) (1994) allows innovation to be protected by the discovery
of new chemical components, know-how in producing the product,
trademarks and trade secrets. However, for herbal medicines it is
difficult to meet all the requirements of patentability due to their
intrinsic characteristics.

Firstly, herbal medicines are crude plant materials, such as leaves,
flowers, fruits, seeds, stems, wood, bark, roots, rhizomes or other
plant parts, which may be entire, fragmented or powdered. As such, it
is often not possible to obtain existing patent law protection for
herbal medicines by claiming the discovery of new chemical entities,
which are novel, involve an inventive step and are industrially
applicable. Secondly, herbal products are powdered herbal materials,
or extracts, tinctures and fatty oils of herbal materials prepared by
steeping or heating herbal materials in alcoholic beverages and/or
honey, or in other materials. The production process is usually
simple. There is no know-how or invention in the preparation process
that is sophisticated enough to justify protection under existing
patent laws. Thirdly, except for pharmaceutical companies and
industries, other holders of traditional knowledge, such as research
institutes and practitioners, often do not have the financial and
human resources that are necessary to obtain protection through
trademarks. Fourthly, it is extremely difficult, if not impossible, to
keep knowledge a secret, because disclosure of the composition of the
product is a prerequisite for registration of herbal medicines before
the product can be sold.

The identification of TK/assigning property right to the medicinal
knowledge, five major analytical steps have to be considered.	i)
subject matter of IPR i.e. information categories that would be called
as knowledge in this category, ii) Identification of beneficiaries,
iii) contribution to biodiversity conservation and appropriate
mechanism for the same, iv) specific attributes of any chosen system
of IPR like duration, enforcement mechanism etc and v) implementation
mechanisms.

Regarding these issues major consideration should include, i) the
protective mechanism should take into account the ethic laws of the
community, who own the knowledge, ii) sharing authorities should
decide for further proceeding forum depends on the intention of
protection, for example, whether we are looking for trade benefits
(then WTO), or proceed it as a major health care system and to be
incorporated to the 'mainstream' medicine (then WHO), iii) Immediate
need to develop the sharing benefits mechanism of cumulative
innovations, which consider all the involved stakeholders. The recent
models, like Bhagirathy (2003), are relevant in this concern and iv)
possibilities should be explored not only to develop a sui generis
system, but inclusion in geographic indication should also be
explored.

d)	Easing the Power Relations and Framing an Adequate Export Policy

To an extent, the policy framed by the major export destinations, like
USA, UK and other European nations, have the ability to decide the
role of Traditional medicine in the world market. Thus the 'selling
benefits' from ayurveda largely depend on the destination policies.
Many herbal products fall between the far ends of this regulatory
range: unlicensed preparations are thought to account for over 80 per
cent of herbal sales (De Smet, 1995). European Union legislation
requires herbal products to be authorized for marketing if they are
industrially produced and if their presentation or their function, or
both, bring them inside its definition of a medicinal product.
Unfortunately, the drawing of sharp borderline is difficult. Many
medicine-like products on the British herbal market remain
unregistered for two reasons: acceptable data on efficacy, safety and
quality may not be available, and the licensing fee is high (De Smet,
1995). Special licensing procedures for herbal medicines are already
in force in Germany, where regulatory evaluations of medicinal herbs
have been laid down in more than 300 monographs, and in France more
than 200 herbs have been listed as acceptable ingredients of
phytomedicines. Australia developed an integral approach to the herbal
market that will also cover various non-western herbs. The main
registering and regulating body for Western herbal practitioner is the
National Institute of Medical Herbalist situated in U.K. Only
graduates of approved courses are accepted on to the register, and a
strict code of ethics is maintained. The European Herbal Practitioner
Association, an umbrella body with about 1000 members, has been set up
to encourage greater unity among herbalists. However, it has no formal
criteria for screening membership and no published code of ethics yet
(Vickers and Zollman, 1999).

What is striking is that WHO has been accepted the Chinese yardstick
for standardization of the traditional medicines, which is of a more
evidence based and scientific, which compels India to go for the
scientific validation of their products. The guidelines set for good
practices, in manufacturing, agriculture, validation or clinical
trials (GCP< GMP< GAP) are accepted as a common requirement for
acceptance. Many countries have been taken very abrasive steps
regarding the traditional medicine, might be the pressure from the
lobbies of other medicines.  From 2000, the EU has drafted a series of
directives that seriously restrict the practice of herbal medicine,
with the intent of a suitable choice on consumer choice and public
safety. A house of lords have been appointed in 1999-00 in Britain to
enquire into various science and technology aspects. Since 2000, this
British House of Lords and the Government have been working towards a
regulatory scheme for Complementary and alternative medicine in
Britain, a scheme that will include ayurveda. House of Lords Select
Committee on Science and Technology produced six reports, the last of
which was entitled 'Complementary and Alternative Medicine '
(henceforth the 'Report'). The report, of which most of the
recommendations have been agreed upon by the government have raised a
big protests from the CAM practitioners and manufacturers. The report
classifies the Traditional medicines into three sections, in which
ayurveda has been included in the third category, advocates strong
evidence to prove its efficacy (for detailed discussion see Wujastyk,
2004). There are criticisms that this document has prepared without
considering the available knowledge about different traditional
medical systems, and been not helpful in bringing out more truthful
deliberations on the same. It is also regrettable that such a bluntly
hegemonic approach to CAM has been the informing principle behind
these documents, in stark contrast, for example, to the approaches
taken by the WHO (Wujastyk, 2004). So the industry, academia and
government have to keep on track of the larger power relations in the
world herbal market, because that can be a decisive factor ultimately,
though whatever efforts effectively we put up (Banerjee, 2004). US
Department of Health and Human Services (DHHS) and the agencies under
that, strongly acknowledges the need for scientifically proven CAM
practices, to integrate the same to modern medicine and mainly insists
on research, outreach and integration. For the effective integration,
it has been mentioned as a clause that the published research work
will only be considered. So the validation should be in the modern
norms.

Since, these kinds of regulations, exist in other countries, the
manufacturers are exporting medicines in food supplement and
cosmeceuticals category, from which the manufacturers are gaining
much. This fetches them additional tax benefits too. Now Ayurvedic
medicines are exported to UAE and Malaysia. Singapore and Germany are
emerged to be the new destinations and opens new potentials and
possibilities. . But the solution will be as we mentioned earlier,
proper in house validation and standardization along with our own
well-developed modern Ayurvedic pharmacopoeia and bring more
transparency in listing the documents and ingredients.


regards
Hari

alt. email: harims at cds.ac.in